D-1042-2014 Class II Terminated
FDA drug recall D-1042-2014 was initiated by Wockhardt Usa Inc. on Nov 27, 2013 and is designated Class II. Reason for recall: Failed Dissolution Specifications; 12 month acid dissolution test results were above upper limit specifications. The recall status is terminated (terminated Jan 29, 2015). Affected quantity: 1129 bottles.
Recall details
- Product Type
- Drugs
- Report Date
- Feb 5, 2014
- Initiation Date
- Nov 27, 2013
- Termination Date
- Jan 29, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1129 bottles
Product description
Pantaprazole Sodium Delayed Release Tablets , USP 40 mg, 1000 tablets bottle, Rx only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd Parsippany, NJ 07054 USA. NDC: 64679-0434-02.
Reason for recall
Failed Dissolution Specifications; 12 month acid dissolution test results were above upper limit specifications.
Distribution pattern
Nationwide including Puerto Rico
Code information
Lot: #: DM12286, Expiry: 06/14.
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-1042-2014
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026